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primary studies published RCT

The long-term safety of chronic azithromycin use in adult patients with cystic fibrosis, evaluating biomarkers for renal function, hepatic function and electrical properties of the heart.

  • Year: 2021
  • Date: 1987
  • Author: Akkerman-Nijland AM
Source

Expert Opin Drug Saf. 2021 Aug;20(8):959-963. doi: 10.1080/14740338.2021.1932814. Epub 2021 Jun 7.

Study design (if review, criteria of inclusion for studies)

open, randomised crossover study

Interventions

microspheres of pancreatin were compared with a standard preparation of enteric coated pancreatin over two consecutive 28 day treatment periods. Lipase intake was equal to the patients' previous requirements and was the same during the two months.

Outcome measures

Patients performed 72 hour faecal collections at the end of each month and completed diary cards daily throughout.

Main results

Comparison of the month of treatment with enteric coated microspheres with the month of standard enteric coated tablets showed a significant increase in body weight on microsphere capsules (p less than 0.02). There was also a reduced frequency of bowel actions (p less than 0.001) and abdominal pain (p less than 0.05), and improvement in stool character (p less than 0.001) on microsphere capsules. Faecal fat excretion was reduced by 44% with the microsphere capsules (p less than 0.01), and 86% of patients showed an increased coefficient of fat absorption (mean increase 13%, 95% confidence limits 6.5-19.1%; p less than 0.001). Eighty one per cent of patients preferred microsphere capsules of the two treatments

Authors' conclusions

enteric coated microsphere capsules are more effective in treating steatorrhoea in cystic fibrosis than standard enteric coated tablets.

Keywords: Adult; Capsules; Enteric-Coated; Microspheres; pharmacological_intervention; Pancreatic Enzyme Replacement Therapy; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Gastrointestinal Agents;